CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST

K981882 · Princeton BioMeditech Corp. · MMI · Jul 6, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981882
• Device Name: CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST
• Applicant: Princeton BioMeditech Corp.
• Product Code: MMI · Clinical Chemistry
• Decision Date: Jul 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Intended Use

The Cardiac STATus™ CK-MB/Myoglobin/Troponin I Rapid Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of CK-MB, myoglobin and troponin I in human whole blood, serum, and plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care and hospital settings.

Device Story

Cardiac STATus™ is an in vitro diagnostic test for qualitative detection of CK-MB, myoglobin, and troponin I; used as an aid in diagnosing myocardial infarction. Input samples include human whole blood, serum, or plasma. Device is intended for professional use in emergency rooms, critical care, point-of-care, and hospital settings. Results provide rapid clinical information to assist healthcare providers in the assessment of patients with suspected cardiac events. Device facilitates timely clinical decision-making regarding patient management.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

In vitro diagnostic test for qualitative determination of cardiac markers (CK-MB, myoglobin, troponin I). Form factor is a rapid test device. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for the rapid qualitative detection of CK-MB, myoglobin, and troponin I in human whole blood, serum, or plasma to aid in the diagnosis of myocardial infarction in patients presenting in emergency, critical care, or point-of-care settings. For professional use only.

Regulatory Classification

Identification

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL ୧

Jemo Kang, Ph.D. . President Princeton BioMeditech Corporation P.O. Box 7139 08543-7139 Princeton, New Jersey

K981882 Re : Cardiac STATus™ CK-MB/Myoglobin/Troponin I Rapid Test Requlatory Class: II Product Code: JFX, MMI, DEA May 26, 1998 Dated: May 28, 1998 Received:

Dear Dr. Kang:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "[e-mail]".

Sincerely yours,

Steven Autman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Princeton BioMeditech Corp Cardiac STATus™ CK-MB/Myoglobin/Troponin I Rapid Test 510(k) Notification

## 510(k) Number (if Known) : Not Known at this time

Device Name : Cardiac STATus™ CK-MB/Myoglobin/Troponin I Rapid Test

Indications for Use:

The Cardiac STATus™ CK-MB/Myoglobin/Troponin I Rapid Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of CK-MB, myoglobin and troponin I in human whole blood, serum, and plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care and hospital settings.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Professional use: X

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use (Optional Format 1-2-96)

Caul Benson/Alfred Montgomery

(Division Sign-Off) Division of Clinical 510(k) Number